The present invention relates to fluid path connectors and container spikes for fluid delivery and, particularly, to fluid path connectors and container spikes for delivery of sterile, medical fluids.
The following information is provided to assist the reader to understand the invention disclosed below and the environment in which it will typically be used. The terms used herein and objectives described herein are not intended to be limited to any particular narrow interpretation unless clearly stated otherwise in this document. References set forth herein may facilitate understanding of the present invention or the background of the present invention. The disclosure of all references cited herein are incorporated by reference.
In many medical procedures, such as diagnostic and/or therapeutic drug delivery, it is desirable to inject a fluid into a patient. For example, numerous types of contrast media (often referred to simply as contrast) are injected into a patient for many diagnostic and therapeutic imaging procedures. In some medical procedures (for example, computed tomogrophy (CT), angiography, and nuclear magnetic resonance/magnetic resonance imaging (MRI)) it is desirable to deliver a liquid such as contrast medium in a timed fashion under relatively high pressures. Such relatively high pressures and timed boluses are typically achieved through the use of powered injectors.
To, for example, optimize contrast volume delivery, minimize waste of contrast and facilitate injector procedures for operators, fluid delivery systems that are capable of delivering sufficient contrast for multiple injection procedures from a single source of contrast have recently been developed. Examples of such systems are described generally in U.S. Pat. Nos. 5,569,181, 5,806,519, 5,843,037 and 5,885,216, the disclosures of which are incorporated herein by reference. Typically, it is desirable that such fluid delivery systems include a fluid path with a disposable patient interface that is changed/discarded between each patient to reduce the potential for cross-contamination.
A fluid path connector to connect to a source of fluid is required to incorporate a removable/disposable patient interface in the fluid path of a fluid delivery or injector system. However, many fluid path connectors used in medical procedures exhibit a number of substantial drawbacks including, for example, difficulty of use and difficulty in maintaining sterility. Moreover, when such connectors are used at high pressures, leakage and failure also become substantial problems.
Often a piercing member of spike is used to form a fluid connection with a fluid source or container via puncturing of an elastomeric septum or stopper on an outlet of the container. In addition to problems associated with, for example, difficulty of use and difficulty in maintaining sterility, it is often difficult to provided a suitable flow rate for certain medical procedures (for example, delivery of a relatively viscous fluid such as a contrast medium) from spike connectors. The spike of such fluid connectors is typically of limited cross-sectional area to facilitate piercing, resulting in significant limits upon the size of the fluid line or channel passing through the spike. For example, even the largest fluid line in currently available spike fluid connectors have a cross-sectional area of approximately 0.08 in2, significantly limiting the flow rate of fluids therethrough.
It is desirable to develop improved fluid path connectors for fluid delivery that, for example, reduce or eliminate the above and/or other problems associated with currently available fluid path connector and spikes.